MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
NCT ID: NCT06627673
Last Updated: 2024-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-01-01
2028-03-01
Brief Summary
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Detailed Description
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PEEK is a high-performance, engineering thermoplastic characterized by an unusual combination of properties. These properties range from high temperature performance to mechanical strength and excellent chemical resistance.
The PEEK-OPTIMA® femoral component, is an investigational device and is the subject of this study approved for IDE by the Federal Food and Drug Administration (FDA).
Maxx Orthopedics, Freedom Total Knee System is used with instrumentation to assist with surgery of the knee. The Maxx Orthopedics, Freedom Total Knee System implants are approved by the FDA for use in the United States and is not investigational.
All patients will receive the Freedom Total Knee System with the PEEK femoral component. Patient / study participents' records will be reviewed for identification of any and all complications, post-operative care, component safety and efficacy, and if re-operation is needed.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Treatment arm utilizing primary TKA with PEEK femoral component
This study is a single arm, multi-center, prospective IDE trial. Two hundred (200) patients recruited and consented will receive the PEEK-OPTIMA™ Femoral Component and results will be compared to matched historic controls from the Maxx Orthopedics Freedom Total Knee System product registry (PK-00002 REV-01, WCG IRB# 20241890). Male and female patients 18 years of age or older with Knee Society Score (KSS) of \>25 and \<75 will be eligible for enrollment.
Total Knee Arthroplasty
Primary Total Knee Arthroplasty with a PEEK femoral component
Interventions
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Total Knee Arthroplasty
Primary Total Knee Arthroplasty with a PEEK femoral component
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with a primary diagnosis of end-stage symptomatic unilateral primary knee osteoarthritis.
* Subjects with a pre-operative Knee Society Score (KSS) Knee score of \>25 and \<75.
* Subjects who, in the opinion of the Investigator, can understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
* Subjects who can give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Exclusion Criteria
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
* Subjects who have participated in a clinical study with an investigational product in the last 6 months.
* Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e.: muscular dystrophy, polio, neuropathic joints).
* Subjects with known osteoporosis and/or previous history of fracture related to osteoporosis.
* Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus.
* Subjects defined by the Investigator as American Society of Anesthesiologists (ASA) Grade III or IV.
* Subjects who have a neuromuscular or neurosensory deficit.
* Female subjects who are pregnant or lactating.
* Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
* Subjects with primary or secondary diagnosis of inflammatory or traumatic arthritis.
* Subjects with a fixed flexion deformity of over 20 degrees.
* Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
* Subjects who have previously undergone surgery on the indicated knee including total knee arthroplasty, patellofemoral arthroplasty, or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, fusion, open reduction and internal fixation.
* Subjects that have undergone, or scheduled to undergo, contralateral total knee arthroplasty or unicondylar knee arthroplasty within ±1 year from the study surgical procedure.
* Evidence of active or suspected (systemic or local) infection at time of surgery.
18 Years
ALL
No
Sponsors
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Maxx Orthopedics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Asit Shah, MD, PhD
Role: STUDY_CHAIR
Chief of Orthopedics - Englewood Hospital
Central Contacts
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References
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Berend KR, Lombardi AV Jr, Mallory TH. Rapid recovery protocol for peri-operative care of total hip and total knee arthroplasty patients. Surg Technol Int. 2004;13:239-47.
Jamsen E, Puolakka T, Eskelinen A, Jantti P, Kalliovalkama J, Nieminen J, Valvanne J. Predictors of mortality following primary hip and knee replacement in the aged. A single-center analysis of 1,998 primary hip and knee replacements for primary osteoarthritis. Acta Orthop. 2013 Feb;84(1):44-53. doi: 10.3109/17453674.2012.752691. Epub 2012 Dec 17.
Durbhakula SR, L. Restoration of Femoral Condylar Anatomy for Achieving Optimum Functional Expectations: Component Design and Early Results. Recon Review 6(3): 5, 2016
Durbhakula SD, V.; Durbhakula, N. Restoration of Femoral Condylar Anatomy for Achieving Optimum Functional Expectations: Continuation of an Earlier Study At 5-Year Minimum Follow-Up. Recon Review 9(1): 6, 2019
Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.
Lyman S, Lee YY, Franklin PD, Li W, Cross MB, Padgett DE. Validation of the KOOS, JR: A Short-form Knee Arthroplasty Outcomes Survey. Clin Orthop Relat Res. 2016 Jun;474(6):1461-71. doi: 10.1007/s11999-016-4719-1. Epub 2016 Feb 29.
Shim J, Hamilton DF. Comparative responsiveness of the PROMIS-10 Global Health and EQ-5D questionnaires in patients undergoing total knee arthroplasty. Bone Joint J. 2019 Jul;101-B(7):832-837. doi: 10.1302/0301-620X.101B7.BJJ-2018-1543.R1.
Thomsen MG, Latifi R, Kallemose T, Barfod KW, Husted H, Troelsen A. Good validity and reliability of the forgotten joint score in evaluating the outcome of total knee arthroplasty. Acta Orthop. 2016 Jun;87(3):280-5. doi: 10.3109/17453674.2016.1156934. Epub 2016 Mar 3.
Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
Other Identifiers
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PK-00001
Identifier Type: -
Identifier Source: org_study_id
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